Evaluate Tolerability of a Recombinant DNA HIV-1 Vaccine in Healthy Adults

Inclusion Criteria:

• Healthy adults; age greater than 18 years, less than or equal to 40 years
• HIV-1 negative as documented by negative ELISA and negative Western blot analysis within 30 days prior to immunization
• Normal history and physical exam

• Normal complete blood count and differential obtained within 60 days prior to immunization, and defined as:

  • hemoglobin greater than or equal to 12.0 gm/dl for females and greater than or equal to 14.0 gm/dl for males
  • white blood cell count greater than or equal to 3500 cells/mm3
  • platelet count between 150,000 and 550,000 cells/mm3
  • CD4+ T cell count greater than or equal to 400 cells/mm3 (if a single CD4+ T cell count <400 cells/mm3 is obtained, a repeat count will be performed and immunization will proceed if the repeat count is greater than or equal to 400 cells/mm3)
• Anti-nuclear antibody titer <1:80 (by IFA) and negative anti-DNA antibody within 60 days prior to immunization
• Negative for Hepatitis B surface antigen and Hepatitis C
• AST and ALT within normal institutional limits obtained within 60 days prior to immunization
• Serum creatinine, Na+, K+ and Cl- within normal institutional limits, obtained within 60 days prior to immunization
• Serum creatine phosphokinase (CPK) within normal institutional limits obtained within 60 days prior to immunization
• Not planning to become pregnant during study vaccinations and for three months after last vaccination
• Availability for at least one year of follow-up

Exclusion Criteria:

• History of immunosuppressive illness, chronic illness (e.g. asthma, diabetes, hypertension, bleeding diathesis, etc), or
• Receiving therapy or prophylaxis for tuberculosis
• Medical or psychiatric condition or occupational responsibilities which preclude subject compliance with the protocol. Specifically excluded are persons with a history of suicide attempts, recent suicidal ideation or who have past or present psychosis
• Live attenuated vaccines within 60 days of study enrollment (Note: subunit or killed vaccines [e.g. influenza or pneumococcal] are not exclusionary, but should be given at least 2 weeks before or after HIV immunization)
• Use of experimental agents within 30 days prior to study enrollment
• Receipt of blood products or immunoglobulin in the past 6 months
• Subjects with known allergy to the antibiotic kanamycin
• Pregnancy at the time of vaccination (urine pregnancy test)
• Nursing mother at the time of vaccination
• Any member of the Investigator's laboratory program
• Participation in previous HIV vaccine trial